Vitamin B6

Single-ingredient vitamin B6 reference formula at 100 mg per serving, developed as a tablet or capsule, with smaller-amount options.

Vitamin B6 is a reference formula for brands building a single-ingredient B-vitamin product around the amounts seen on reference labels. The default amount is 100 mg per serving, and the development work centers on the form of vitamin B6 (pyridoxine hydrochloride or pyridoxal 5′-phosphate), the weight of salt that carries 100 mg of vitamin B6, and the amount tier for each sales market.

Tablet is the lead format because the pyridoxine salt weighs little and a small compressed unit carries it, while the capsule version uses the same salt in a standard fill. Options of 25 and 50 mg sit beside the default, and the 100 mg default matches the adult upper intake level, so the tier is settled with the market review.

Ingredient Composition

IngredientPer ServingRaw Material FormAlternative Form (same amount of active)
Vitamin B6100 mg (default amount)Pyridoxine hydrochloride, specified as vitamin B6 on a pyridoxine basis; 100 mg vitamin B6 per servingPyridoxal 5′-phosphate (the coenzyme form) with the input and label basis set from the supplier specification

Amounts are stated as mg of vitamin B6 expressed as pyridoxine (C8H11NO3, 169.18 g/mol; PubChem CID 1054). Pyridoxine hydrochloride (C8H12ClNO3, 205.64 g/mol; CID 6019) is 82.3% pyridoxine by weight, so 100 mg of vitamin B6 needs about 121.5 mg of the salt. Pyridoxal 5′-phosphate (C8H10NO6P, 247.14 g/mol; CID 1051) is a different form, and its label basis is set with the supplier rather than converted here.

Intended Benefits & Formula Rationale

This formula is designed for products positioned around daily vitamin B6 intake. Vitamin B6 is included as the single active so that the form, the amount and the excipient system can be set without interaction with other actives.

Intended Benefit DirectionKey IngredientsFormulation Rationale
Daily vitamin B6 intakeVitamin B6Included as a water-soluble vitamin that occurs naturally in many foods and in three natural forms: pyridoxine, pyridoxal and pyridoxamine [2]. Evidence: Referenced
Nutrition during pregnancyVitamin B6A meta-analysis of 18 studies found that pyridoxine alone or with another active ingredient improved nausea scores in nausea and vomiting of pregnancy [1]. Evidence: Referenced

A single stated amount lets the brand pick one tier per market. A systematic review reports that both low and high vitamin B6 intakes have been described as risk factors for peripheral neuropathy, and that current evidence supports a neurotoxic role at high levels [2], so the amount is a decision for the brand and its market review.

Available Formats

The vitamin B6 reference formula is built for a tablet version and a capsule version; counts per serving are design choices that the brand can adjust.

FormatUnitPer ServingPack SizeOther Ingredients (typical)Suitability
Tablet1 tablet100 mg60 or 100 tabletsDicalcium phosphate, cellulose, croscarmellose, silica, stearic acidLead format; small compressed unit
Capsule1 capsule100 mg60 or 90 capsulesCellulose, flow agent, capsule shellSalt in a standard fill

Raw Material Input & Fill (Design Estimate)

Design estimates. The input is the vitamin B6 amount divided by the pyridoxine content of the salt at an assumed 100% assay: pyridoxine hydrochloride at 82.3% gives 121.5 mg of salt for 100 mg of vitamin B6.

FormatRaw Material Input per UnitDesign FillBalance for ExcipientsVerification Before Scale-Up
Tablet121.5 mg260 mg tablet weight138.5 mgHardness, disintegration, content assay of vitamin B6
Capsule121.5 mg220 mg per capsule98.5 mgFill weight variation, flow, content assay of vitamin B6

Powder, liquid and gummy versions are separate projects, because a vitamin B6 dose at the adult upper intake level calls for a separate dosing and stability review in those systems.

Formulation Considerations

Dose against the upper intake level. The NIH Office of Dietary Supplements lists 100 mg per day of vitamin B6 as the tolerable upper intake level for adults aged 19 and older [3]. The default amount equals that level, so the amount tier is set in the market review before pilot work, and 25 and 50 mg are carried as options.
Neurotoxicity at high levels. The systematic review in [2] describes a predominantly sensory axonal neuropathy that follows high vitamin B6 levels from supplements and improves after pyridoxine is stopped. Label statements and the amount tier for the finished product are reviewed against this finding.
Salt or coenzyme form. Pyridoxine hydrochloride is the high-yield salt in this design. Pyridoxal 5′-phosphate is the coenzyme form and differs in cost, stability and label basis, so the form is stated on the formula and the label rather than left as the words vitamin B6.
Label basis. The label amount is vitamin B6 expressed as pyridoxine, not the weight of the hydrochloride. The specification states the assay of the salt and the content assay of finished units is run as vitamin B6.

Customization Options

Brands adjust the amount per serving, the vitamin B6 form, the format and the add-ons.

ParameterRangeNote
Amount per serving25, 50 or 100 mgOptions for the brand; each tier is checked against the limit of the sales market
Vitamin B6 formPyridoxine hydrochloride or pyridoxal 5′-phosphateInput and label basis differ by form
FormatTablet or capsulePowder, liquid and gummy are separate projects
Pack size30 to 120 unitsSet by the brand
Add-onsMagnesium, vitamin B12, folateA second active reshapes the unit weight and the specification

The pilot run confirms tablet hardness and disintegration, capsule fill weight and flow, and the content assay of the first units against the labeled amount of vitamin B6.

Technical Status & Data Sources

ItemStatusDetails
Reference formulaNIH DSLDThe ingredient and amount come from a labeled product in the NIH DSLD (100 mg on the label of CF001126; example DSLD labels 7362, 7566, 7748). The label names the ingredient as vitamin B6; pyridoxine hydrochloride is set as the form.
SpecificationSet in formulationPyridoxine hydrochloride, 100 mg vitamin B6 per serving on a pyridoxine basis; assay, impurity limits and method are fixed with the supplier. Unit size, fill weight and stability are set in formulation.
Data sourceNIH DSLDDSLD v9.4.0, downloaded 2026-01-10: 50,824 reference formulas merged from on-market labels with complete ingredient amounts. Counts show how labels are distributed.
Market reviewPer marketDose limits, labeling and claims are reviewed for each sales market before a finished product is developed.
ReferencesSources[1] Jayawardena R, Majeed S, Sooriyaarachchi P, et al. The effects of pyridoxine (vitamin B6) supplementation in nausea and vomiting during pregnancy: a systematic review and meta-analysis. Arch Gynecol Obstet. 2023;308(4):1075-1084. DOI · PubMed<br>[2] Muhamad R, Akrivaki A, Papagiannopoulou G, et al. The Role of Vitamin B6 in Peripheral Neuropathy: A Systematic Review. Nutrients. 2023;15(13):2823. DOI · PubMed<br>[3] NIH Office of Dietary Supplements. Vitamin B6: Fact Sheet for Health Professionals. Source

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